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Square Toe Ortho Wedge Healing Shoe
EUDAMEDClass I (EU MDR)
Ref JX13005Model Lower Limb Orthoses
Identity
- Trade Name
- Square Toe Ortho Wedge Healing Shoe EUDAMED
- Model / Reference
- Lower Limb Orthoses EUDAMEDJX13005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867217401 EUDAMED
- Basic UDI-DI
- 697886721LO000R5 EUDAMED
- Direct Marketing DI
- 06978867217401 EUDAMED
- EMDN Code
- Y0699 EXTERNAL PROSTHESES AND ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Square Toe Ortho Wedge Healing Shoe by Medi Global Assistive Device Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697886721LO000R5 | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED ed8e972b-5405-4685-9971-195b1a589bd9 61 fields · synced Jul 11, 2026